Pragmatic clinical trials experienced significant impacts of COVID-19 on trial activities, according to a survey of NIH Pragmatic Trials Collaboratory Trials published last month in Trials.

Since the beginning of the COVID-19 pandemic in March 2020, many of the NIH Collaboratory Trials have had to postpone recruitment, alter methods of participant engagement, and modify tools for research assessment and intervention delivery. Trial delays often created statistical challenges, especially for those using stepped-wedge designs.

Most of the study teams were able to work closely with healthcare system partners to adapt their study interventions. Some of the adaptations resulted in better participant outreach and the ability to study virtual intervention delivery methods. All of the NIH Collaboratory Trials were able to adapt to pandemic-related changes.

In a recent video interview, lead author Dr. Emily O’Brien praised the study teams.

“We certainly did see some degree of disruption, but I was impressed by the flexibility in the ability to adapt that all of our NIH Collaboratory Trial teams showed,” said O’Brien. “Some of them mentioned the support of having the [Core Working Groups] and consultations with experts in real time to be able to make adjustments,” she said.

The NIH Collaboratory published a tool last year to assist investigators in identifying impacts of the COVID-19 pandemic on ongoing pragmatic trials. The Statistical Analysis Plan Checklist for Addressing COVID-19 Impacts summarizes impacts on trial conduct that study teams should document, measure, analyze, and report.